Advanced Parkinson's Disease Clinical Trial
Official title:
An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications
The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.
The study was composed of a screening period followed by 3 sequential on-treatment periods,
as follows:
- Screening Period (up to 28 days): determination of eligibility and discontinuation of
antiparkinsonian disease medications other than levodopa-carbidopa immediate release
(LC-oral) prior to nasojejunal (NJ) tube placement.
- NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments,
placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG)
treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube
placement but hospitalization was not required for entire duration of LCIG treatment
optimization).
- PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube;
further optimization of LCIG treatment.
- Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a
permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical
condition.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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